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Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120782
First Posted: May 11, 2010
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.

Condition Intervention
Astigmatism Device: etafilcon A toric contact lens with new wetting agent Device: etafilcon A toric contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Prescription Equivalence [ Time Frame: after 15 minutes of lens wear ]
    Number of subjects whose prescription is the same for the two lenses tested.


Enrollment: 45
Study Start Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etafilcon A toric new lens/etafilcon A toric lens
The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
Device: etafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Device: etafilcon A toric contact lens
Marketed toric contact lens made of etafilcon A material.
Active Comparator: etafilcon A toric lens/etafilcon A toric new lens
The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
Device: etafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Device: etafilcon A toric contact lens
Marketed toric contact lens made of etafilcon A material.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must be between 18 and 40 years old.
  2. The subject must have normal eyes.
  3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
  5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
  6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
  7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
  8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.
  9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
  10. Subjects must already possess a wearable pair of spectacles. -

Exclusion Criteria:

  1. Ocular or systemic allergies or disease that may interfere with contact lens wear.
  2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
  3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Pregnancy or lactation
  8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  9. Diabetes
  10. Strabismus -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120782


Locations
United States, Florida
Jacksonville, Florida, United States
United States, New York
New York, New York, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01120782     History of Changes
Other Study ID Numbers: CR-1476AI
First Submitted: May 4, 2010
First Posted: May 11, 2010
Results First Submitted: November 4, 2011
Results First Posted: December 8, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases